BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYSTEM 6 ASEPTIC HOUSING ASSY

    MDR report key: 3883610 · Received June 19, 2014

    Report

    Report Number
    0001811755-2014-02196
    Event Type
    Malfunction
    Date Received
    June 19, 2014
    Date of Event
    May 23, 2014
    Report Date
    May 23, 2014
    Manufacturer
    STRYKER INSTRUMENTS-KALAMAZOO
    Product Code
    HWE
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE REPORTED EVENT, RUBBER SEAL IS MISSING, WAS DUPLICATED. BASED ON A REVIEW OF RISK DOCUMENTS, THE O-RING (RUBBER SEAL) CAN BE DAMAGED AND THUS FALL OUT OF THE HOUSING DUE TO DAMAGE FROM FATIGUE OR EXPOSURE TO CLEANING SOLVENTS. DEVICE WAS PLACED IN PARTS RETENTION.

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS BEEN RECEIVED, FAILURE ANALYSIS IS IN PROGRESS; ADDITIONAL INFORMATION WILL BE SUBMITTED ONCE THE QUALITY INVESTIGATION IS COMPLETED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT RUBBER SEAL IS MISSING FROM SYSTEM 6 ASEPTIC HOUSING ASSEMBLY WHICH CAN CAUSE HOUSING TO NOT CLOSE PROPERLY AND LEAD TO STERILITY BREACH. IT WAS FOUND ON THE SERVICE FLOOR AT MANUFACTURER FACILITY. NO ASSOCIATED PROCEDURE, NO PATIENT INVOLVEMENT, NO DELAY, NO MEDICAL INTERVENTION AND NO ADVERSE CONSEQUENCES WERE REPORTED WITH THIS EVENT

    Description of Event or Problem · 1

    IT WAS REPORTED THAT RUBBER SEAL IS MISSING FROM SYSTEM 6 ASEPTIC HOUSING ASSEMBLY WHICH CAN CAUSE HOUSING TO NOT CLOSE PROPERLY AND LEAD TO STERILITY BREACH. IT WAS FOUND ON THE SERVICE FLOOR AT MANUFACTURER FACILITY. NO ASSOCIATED PROCEDURE, NO PATIENT INVOLVEMENT, NO DELAY, NO MEDICAL INTERVENTION AND NO ADVERSE CONSEQUENCES WERE REPORTED WITH THIS EVENT

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    359977 SYSTEM 6 ASEPTIC HOUSING ASSY INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED MOTOR AND ACCESSORY/ATTACHMENT HWE STRYKER INSTRUMENTS-KALAMAZOO 13210

    Patients

    Seq Age Sex Outcome Treatment
    1